The framework for traditional business models for clinical studies has been rather stable over the last few decades. In such a business model, a sponsor (such as a pharmaceutical company which has developed a new drug, for example) paid all participants which performed in the study. At a minimum, these included participating patients and a medical doctor (an investigator) in charge of supervising the patients. In many cases, an investigation or clinical trial site (e.g., a hospital) was additionally included, where one or more investigators was employed.
So-called contract research organizations (CROs) further established their services in the workflow chain of clinical studies, in between the sponsor on one end, and the investigator and patients on the other. The CRO often took over the complete management of the clinical study, including all necessary services including, for example, development of study protocol, recruiting patients and investigators and/or investigation sites, contracting the participants, supervising the conductance of the study, collecting and evaluating data, channeling the payment from the sponsor to the participants, etc. Of course, for such services, the CRO received a substantial part of the aforementioned payment for their own services.
When recruiting the patients, the CRO, or even the sponsor, tended to use and still uses crude methods wherein prospective patients fill out forms and are screened as candidates for clinical studies. The data utilized is normally that obtained from the patient himself or herself. Regarding the investigator or investigator/clinical trial site chosen to conduct/monitorletc. the study, information previously obtained by the sponsor or CRO was typically used. However, this was often a slow process which often did not produce an ideal patient, investigator and/or investigator/clinical trial site.
FIG. 1 illustrates a typical traditional system for use in connection with clinical studies. Initially, a sponsor 100 (such as a drug manufacturer, for example) defines the study requirements or criteria (study parameters, study protocol, etc.) for the particular clinical study in question. A CRO 120 may then be employed to manage the study, noting that the CRO 120 may develop the study requirements or criteria of the clinical study or may assist therein. The CRO may also assist in recruiting patients for the study, as well as selecting an appropriate investigator/investigators and appropriate clinical trial site(s). If a CRO is involved, the CRO is paid by the sponsor 100. The CRO then manages the study and then pays others involved in the study including investigators 130, patients 140, and potentially investigation or clinical trial sites such as hospitals, for example (not shown).
In addition, the quality of the data acquired must be maintained for proper results in clinical trials, and for the ultimate approval of a new drug, for example. Quality of clinical raw data such as medical images or physiological data can to some extent be checked retrospectively (see, for example German application no. DE 10 2004 008 197.2 entitled “Verfahren zur Qualitätskontrolle von je an unterschiedlichen, aber vergleichbaren Patientenkollektiven im Rahmen eines medizinischen Vorhabens erhobenen medizinischen Datensätzen”, filed Feb. 9, 2004, the entire contents of which are incorporated herein by reference). However, the quality of a database acquired during a clinical study does not only depend on the inherent quality of the raw data (such as signal noise, the wrong use of the measurement device, miscalibration of the device, etc.), but also depends considerably on the workflow context in which the data had been generated. The “standard operating procedure” (SOP) of a clinical trial also regulates many details of the workflow context in which the patient participating in the clinical study has to be treated. This is part of the quality regulations of a clinical trial.
As previously indicated, the requirements for performing a clinical study may be defined in a study protocol, which may be defined by the sponsor 100 and/or the CRO 120. Although participants in the clinical trial confirm, by signing a contract for example, that they are going to comply with the quality regulations, there is no systematic and/or automated way to check this quality compliance. Due to the inability to measure quality compliance in clinical workflow, the payment to the patients, investigators, CRO, investigator/clinical trial sites, etc. does not depend on quality of data.